Device Classification Name |
interventional fluoroscopic x-ray system
|
510(k) Number |
K010435 |
Device Name |
PHILIPS BV PULSERA/ENDURA |
Applicant |
PHILIPS MEDICAL SYSTEMS, INC. |
VEENPLUIS 4-6 |
P.O. BOX 10.000 |
DA BEST,
NL
5680
|
|
Applicant Contact |
MARCIA JONES |
Correspondent |
PHILIPS MEDICAL SYSTEMS, INC. |
VEENPLUIS 4-6 |
P.O. BOX 10.000 |
DA BEST,
NL
5680
|
|
Correspondent Contact |
MARCIA JONES |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/13/2001 |
Decision Date | 03/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|